Pierre Fabre announces start of EU marketing authorization application procedure for Vibegron in overactive bladder

The submission also includes clinical data from the study URO-901-1001, a randomized, Phase 1, double-blind, placebo-controlled, parallel-group study in subjects with OAB, designed to study the effect of Vibegron (at a dose of 75 mg or placebo for 28 days) at steady state on ambulatory blood pressure (BP) and heart rate (HR). Results from this study confirm that Vibegron 75 mg had no statistically significant or clinically meaningful effects on BP or HR in patients with symptoms of OAB.  The...

The submission also includes clinical data from the study URO-901-1001, a randomized, Phase 1, double-blind, placebo-controlled, parallel-group study in subjects with OAB, designed to study the effect of Vibegron (at a dose of 75 mg or placebo for 28 days) at steady state on ambulatory blood pressure (BP) and heart rate (HR). Results from this study confirm that Vibegron 75 mg had no statistically significant or clinically meaningful effects on BP or HR in patients with symptoms of OAB. 

"The submission of the Vibegron application to the EMA is another important milestone for Pierre Fabre, which reinforces its long-standing commitment to the field of urology. We look forward to providing an effective and safe therapeutic response to patients suffering from overactive bladder, to bring them a significant improvement in their quality of life, and thus strengthen our raison d'être "Every time we care for a single person, we make the whole world better", said Eric Ducournau, group CEO at Pierre Fabre.

For more information about Pierre Fabre, please visit www.pierre-fabre.com.

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Press contact:
Anne Kerveillant
anne.kerveillant@pierre-fabre.com

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